- In today’s Recommendation for Industry, we discuss the possibility of COVID transmission from packaging. Read more below.
- Nitric oxide boosts oxygen in pregnant women with COVID-19 pneumonia. Inhaled high-dose nitric oxide (INO200) safely shortened time on supplemental oxygen and hospital stays among pregnant women diagnosed as having severe bilateral COVID-19 pneumonia, suggests a new study led by Massachusetts General Hospital (MGH) researchers. INO200 recipients didn’t require oxygen for as many days as their standard-care counterparts (median days, 22 vs 24). And in multivariable-adjusted analyses, INO200 was tied to 63.2% (95% confidence interval [CI], 36.2% to 95.4%) more oxygen-supplementation-free days, a 59.7% (95% CI, 45.0% to 63.2%) shorter stay in an intensive care unit, and a 63.6% (95% CI, 55.1% to 70.8%) shorter hospitalization.
- The U.S. government will buy 3.2 million doses of Novavax’s COVID vaccine. Although the vaccine has not yet been authorized, it is expected to be soon. This would be the fourth vaccine available in the US. The company hopes that its protein-based shot, a vaccine technology that has been widely used for decades, will appeal to Americans who declined to be vaccinated with shots using messenger RNA technology. Novavax is still meeting the needs of FDA standards and is expected to finish its quality testing within the next few weeks.
- Most Americans say life is starting to return to normal, a poll shows. While 12 percent of adults think their life is the same as it was before the pandemic, 54 percent think their lives are somewhat the same, according to the poll and 34 percent think that their lives are not the same. According to the survey, a slim majority of 51 percent of Americans think that getting a COVID-19 vaccine is essential for them, while 39 percent think that nearly all people need to receive the vaccine before things can go back to the way they were. Only 22 percent think that wearing masks in public indoor places is essential to going back to pre-pandemic life, while 20 percent think regular testing is essential.
- The most recent data provided from CDC with the week ending in July 2 shows there were 0 jurisdictions with very high activity level, 1 with high, 2 with moderate, 2 with low, and 47 with minimal. Based on NCHS mortality surveillance data available on July 7, 2022, 8.8% of the deaths that occurred during the week ending July 2, 2022 (week 26), were due to pneumonia, influenza, and/or COVID-19 (PIC).
Public Health & Food Safety:
- An update from HealthMap.org shows that there was a 95% drop in whooping cough cases in the UK when comparing 2021 to 2020 which is likely due to the imposition of COVID-19 precautions.
- Officials note multiple sex partners as monkeypox risk: The European Centre for Disease Prevention and Control (ECDC) published its first update to its rapid risk assessment of monkeypox, saying that the likelihood of disease spread in people with multiple sexual partners in Europe is high, but the risk to the broader population is very low. Cases globally have reached 8,127, with the vast majority reported in nonendemic European countries, including Spain, Germany, and the United Kingdom. Beginning July 11th, Jynneos vaccine will be made available for US states. From May 17 to Jun 30, Laboratory Response Network (LRN) within the US tested 2,009 specimens for suspected monkeypox, with 730 (36%) specimens from 395 patients showing positives.
- China links seven COVID-19 outbreaks to food packaging: Seven outbreaks and 689 cases were linked to imported cold-chain foods from June 2020 to mid-July 2021, according to the study in China CDC Weekly. Positive swabs came from seafood, poultry meat, and other foods. Outer packaging contamination by SARS-CoV-2 nucleic acid was much more common than inner packaging or the food itself. They added handlers and processors of imported frozen foods should be effectively protected, monitored daily for symptoms of COVID-19, and tested for SARS-CoV-2 nucleic acid at regular intervals. Another survey, published in the same journal, analyzed 56 million samples, 1,455 were positive for SARS-CoV-2 nucleic acid. Out of 1,398 SARS-CoV-2-positive food and packaging materials, all but seven were imported.
- Additive in Barry Callebaut chocolate Salmonella case came from Hungary. The contaminated raw materials that forced Barry Callebaut to halt chocolate production in Belgium came from Hungary. On July 1, Barry Callebaut confirmed that, based on its internal investigation, no affected products had entered the retail food chain and no implicated chocolate has been exported by the company outside Europe. Affected countries include Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Serbia, Spain, Sweden and the United Kingdom, according to a RASFF alert.
- Public health alert issued over rendered pork fat without federal inspection. FSIS was notified by the New York State Department of Agriculture and Markets that the rendered pork fat products were produced and shipped into commerce without the benefit of FSIS inspection. These products are misbranded due to the unauthorized use of the marks of federal inspection. A recall was not requested because the products are no longer available for purchase. However, FSIS is concerned that some product may be in consumers’ refrigerators or pantries. Product subject to the public health alert: 1.8-lb. plastic containers of “MANTECA RENDERED PORK FAT DON PANCHITO;” the products bear establishment number “EST. 19900” inside the USDA mark of inspection.
- Bird flu eases in commercial poultry, but APHIS fears it could return in fall. A world snapshot for the period from May 19 through June 8 by the World Animal Health Information System of the World Organization for Animal Health also shows commercial poultry flocks in the United States have mostly escaped highly pathogenic avian influenza during the past month (HPAI) tapering off. A total of 384 flocks in 36 states have been struck in 2022 by the bird flu. A total of 186 commercial poultry flocks and 198 backyard flocks were infected. While the Animal and Plant Health Inspection Service remains concerned about the virus remaining in wild bird flyways during the summer with the risk of migrating birds bringing it back into the country this fall, it does see a break in the hectic action.
Recommendations for Industry
Question on COVID Transmission from Packaging Resurfaces
New studies out of China have hit the news, bringing back the question of COVID transmission from food/food packaging. As reported by FSN, and detailed in our Key Points above, a China CDC Weekly found 7 COVID outbreaks and 689 cases linked to imported cold-chain food (June 2020 to mid-July 2021) – based on findings of the SARS-CoV-2 nucleic acid primarily on the outer packaging. Another study from the China National Center for Food Safety Risk Assessment found 1,455 of nearly 56 million (0.003%) frozen-food related samples to be positive for SARS-CoV-2 nucleic acid, with the majority again found on food packaging.
Not only is 0.003% an extremely low finding, but it’s not surprising that the SARS-CoV-2 nucleic acid would be found on food packaging, as its presence does not mean that a live virus was detected or that it is a transmissible avenue. Additionally, neither study showed any supporting data evidence that the presence resulted in transmission of the virus.
Overall, if you look hard enough, you will find the nucleic acid on surfaces where infected persons are, but it is not likely to be a significant source of transmission, as we have stated since early in the pandemic. And there has never been any evidence from any studies that food consumption can transmit the virus. So while COVID droplets certainly could be found on surfaces from infected persons, the potential of a person getting COVID from such sources is very unlikely.
In case you missed it:
- In last Thursday’s Recommendation for Industry, we discussed the continued westward movement of COVID in the U.S. Read more here.
- BA.4/5 COVID-19 variants now dominant in all US regions. Combined, the two subvariants make up more than 70% of recently sequenced samples, up sharply from 52.3% the previous week. Of the variants CDC is tracking, BA.5 now makes up 53.6%, and BA.4 makes up 16.5%. In global developments, virologists are closely watching another Omicron variant called BA.2.75 that appears to be competing with BA.5 in India. So far, BA.2.75 hasn’t been designated as a variant of interest or a variant of concern.
- Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. July 6, 2022, the FDA revised the Emergency Use Authorization (EUA) for Paxlovid, to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients (COVID positive individuals 12 years of age and older weighing at least 40 kilograms or about 88 pounds), with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research stated, “since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.” There are some limitations for receiving Paxlovid that can be found here. To receive Paxlovid, a positive COVID individual should bring the following to a state-licensed pharmacist:
- Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
- A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
- COVID-19 third leading cause of death in 2020, 2021– In the first 20 months of the COVID-19 pandemic, the disease accounted for one in eight deaths and was the third leading cause of death in the United States, according to a study published in JAMA Internal Medicine. From March 2020 to October 2021, COVID-19 was one of the top five causes of death in every age group 15 years and older. Overall, the leading causes of death during this time frame was heart disease (20.1%), followed by cancer (17.5%), COVID-19 (12.2%), accidents (6.2%) and stroke (4.7%). In 2020, COVID-19 was the fourth leading cause of death for those aged 45 to 54 years and the fifth leading cause for those aged 35 to 44 years, but it jumped to the first and second leading causes of death in these age groups in 2021. Among adults aged 85 years and older, COVID-19 was the second leading cause of death in 2020 (12.8%) and the third leading cause in 2021 (8.9%).
- COVID-19 Vaccine Doses, Once in High Demand, Now Thrown Away. Governments, drugmakers and vaccination sites are discarding tens of millions of unused COVID-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce. Moderna recently discarded about 30 million doses while there were no takers for it. Germany’s health officials have disposed of about 3.9 million COVID-19 vaccine doses that were sitting in a federal central warehouse and expired at the end of June. Canada has disposed of 1.2 million expired doses of Moderna’s vaccine, and is set to throw out about 13.6 million expired doses of AstraZeneca PLC’s COVID-19 vaccine, according to the government health department. Demand for vaccines may pick up in the fall as those shots will be targeted to prevent against the Omicron variant. On July 6, the U.S. government agreed to purchase 105 million doses of a modified vaccine from Pfizer and BioNTech for a fall booster campaign.
Public Health & Food Safety:
- Study on monkeypox outbreak shows differing symptoms. A new study published in The Lancet Infectious Diseases found that the clinical profile in recent monkeypox cases is different than in past events, with fatigue and fever less common and genital skin lesions more likely. Men who have sex with men (MSM) has played an important role in the reporting of such symptoms. In the study, 47 of 52 men who answered questions on recent sexual history said they had at least one new sexual partner in the 3 weeks prior to symptoms, and 29 of 52 (55.8%) had more than 5 new partners in the 12 weeks prior to diagnosis. Almost all (49/52) patients presented with lesions and rashes on their genitals or anal regions. Only five patients required hospitalization, and no one died. One-quarter of the patients also were diagnosed with another sexually transmitted infection at the same time as monkeypox. US cases of monkeypox are continuing to grow, with Iowa, Wisconsin, and Connecticut reporting their first cases of the virus. According to the Centers for Disease Control and Prevention, the country has 460 cases in 32 states. California currently reports the most cases in the country with 95.
- Global monkeypox cases top 6,000, WHO says. The World Health Organization (WHO) confirmed the global outbreak of monkeypox consists of 7,075 confirmed cases, with 80% in European countries. The European Centre for Disease Prevention and Control (ECDC) and the WHO released a new toolkit aimed at event organizers who wish to minimize the spread of monkeypox at large gatherings. Labcorp will be able to test for monkeypox virus, doubling the nationwide capacity for testing, according to the US Centers for Disease Control and Prevention (CDC).
- FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers. The FDA has prioritized review of requests from firms that can: 1) produce documentation to demonstrate the safety and nutritional adequacy of the product; 2) make the largest volume of product available; and/or 3) get product onto U.S. shelves quickly. The FDA intends to consider enforcement discretion requests until the temporary shortage is addressed. To date the FDA’s flexibilities have resulted in a total estimated quantity of more than 400 million, 8-ounce bottles worth of formula from nine countries for children in the U.S. The enforcement discretion described in the May guidance is set to remain in effect until Nov. 14, 2022. Additionally, the FDA intends to:
- Provide a single technical assistance contact at the FDA for any company aiming to enter the U.S. infant formula market, making it easier for potential new entrants to navigate the FDA’s regulatory review process.
- Host meetings this summer with companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to determine what additional steps would be needed to provide a pathway to long-term, uninterrupted marketing for safe and nutritious formula.
- Provide a pathway for companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to continue to supply infant formula to the U.S. past November.
- FDA completes Food for Animals Guidance as required by FSMA. The U.S. Food and Drug Administration on Wednesday finalized Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals to help animal food facilities subject to the FDA Food Safety Modernization Act (FSMA) Hazard Analysis and Risk-Based Preventive Controls for animal food requirements develop a food safety plan to prevent or significantly minimize hazards that could cause illness or injury to people or animals.